Intrauterine access catheter for delivering and facilitating operation of a medical apparatus for assisting parturition

ABSTRACT

A catheter to access and navigate the uterine cavity through the cervical canal for delivering, deploying, and facilitating operation of a peripheral intrauterine medical apparatus during parturition includes an elongated, flexible tubular catheter body with a handle at the proximal end controlling a steering mechanism and deflecting the distal tip. The catheter includes a lumen that extends the length of catheter body to a distal end region of the catheter. The peripheral medical apparatus is located in the distal end region and is configured to deploy from the distal tip of the catheter into the uterine cavity. A soft catheter tip reduces the likelihood of injury during intrauterine navigation and placement, and sensors associated with the catheter body provide signals that allow for the monitoring of infant, umbilical cord, placenta and uterine muscle activity during labor to assist operation of the peripheral medical apparatus.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims the benefit of U.S. Provisional Application Ser.No. 62/080,506, entitled “Birthing Assistance Catheter” and filed onNov. 17, 2014, and U.S. Provisional Application Ser. No. 62/080,511,entitled “Intracorporeal Birthing Device” and filed on Nov. 17, 2014,each of which is expressly incorporated by reference herein in itsentirety.

This application includes subject matter related to co-pending U.S.patent application Ser. No. ______, entitled “Intrauterine BalloonApparatus, System, and Method for Augmenting Uterine Birthing ForcesDuring Parturition” [Attorney Docket No. 037262.00003], and filed onNov. 16, 2015, which is expressly incorporated by reference herein inits entirety.

BACKGROUND

1. Field

The present disclosure relates to a catheter and more particularly, anintrauterine catheter for accessing and navigating the uterine cavity,infant, placenta and umbilical cord to deliver a medical apparatus at aproximal uterine location for assisting infant descent during activelabor or parturition.

2. Background

There are three physiologic stages of labor during the intrapartumprocess of natural childbirth. The first stage is latent labor andbegins when the uterine muscles begin to tighten (contract) and relax ina periodic manner. These early contractions occur at an irregularfrequency each lasting for less than a minute and are known to beuncomfortable for the mother. The total duration of this first phase ishighly variable and last from several hours to several days. Over timefrequency of the contractions becomes more regular and grows withintensity, resulting in increased intrauterine pressures and associatedpain, causing greater downward forces towards the infant and birth canalleading to the thinning (effacing) and opening (dilation) of the cervix.

The second stage is active labor and begins when the mother's uterinecontractions become more regular and frequent, generating sufficientcoordinated strength towards the infant and birth canal causing thecervix to become thinner and diameter to grow larger for the infant tobegin descending down the birth canal. The combination of intensifyinguterine contractions, increased intrauterine pressures, and reducedbirth canal resistance promotes gradual infant descent through the birthcanal until it is eventually delivered or surgically extracted. Theduration of this stage lasts several hours and is associated with activeinfant movement and significant maternal pain. The third stage followsthe delivery of the infant after which uterine contractions and theintrapartum process continues resulting in the expulsion of theplacenta.

Difficulties often arise during the first and second stage when themother's uterus is unable to generate the required contractility toinitiate and ensure steady progression of the infant down the birthcanal. Furthermore, increased resistance to infant descent by themother's pelvic region along the birth or cervical canal requiresgreater effective birthing forces to ensure infant descent. Asignificant percentage of women therefore experience prolonged durationsof labor which subsequently extends morbidity and increases the risks toboth her and her infant due to extended physical stress.

A significant clinical need exists to manage intrauterine birthingforces for the purposes of assisting, stabilizing, or accelerating thebirthing process during the first and second stage of labor. Currently,when a mother experiences prolonged durations of labor, the mainstaypharmacologic intervention used is synthetic Oxytocin (Pitocin) forstimulating and increasing uterine contractions. Dosages are based onprotocols derived from a combination of population data and individualpatient assessments of contraction rates and birthing progress, butindividual patient's intrauterine pressures are generally not optimizedon a per case basis. Although a very small minority of patients doreceive intrauterine pressure monitors for titrating Oxytocin, labormanagement using individual pressure optimization is not widely accepteddue in large part to data suggesting pharmacologic interventions arelimited with their effectiveness to achieve sufficient pressures. Othermethods of assisting the birthing process include prostaglandins andPessary cervical dilators to reduce the resistance of the birth canal toinfant descent but do not compensate for ineffective uterinecontractions.

In totality these interventions prove to be only marginally effective,and a significant percentage of mothers attempting natural birthseventually undergo a surgical extraction of the infant (Cesarean)through a transverse abdominal incision to directly access the uterinecavity. Because Cesarean surgical interventions are highly invasive andresult in extensive maternal morbidity, an increase of recovery times,and significantly greater risks of uterine injury with future subsequentbirths, a clinical need exists for providing an alternative option inlieu of a Cesarean section intervention by safely enhancing uterinedescent forces and reducing labor durations.

SUMMARY

Disclosed herein is a minimally invasive catheter and method for gainingaccess to a proximal region of the uterus for the purposes ofdelivering, deploying and operating an intrauterine medical apparatus toassist infant descent during natural child birth. The catheter isconfigured to gain access to the intrauterine cavity through thecervical canal, to navigate the intrauterine cavity containing theinfant, placenta and umbilical cord, and to place the medical apparatusbetween the endometrium and infant at a proximal uterine location nearthe fundus. The catheter provides a conduit for the medical apparatusand serves as a platform for one or more sensors to monitor physiologicintrauterine and fetal indicators of parturition progress.

In one aspect, a catheter for directing an intrauterine medicalapparatus within a patient's cervix includes a handle having a proximalend, a distal end, and a port at the proximal end. The catheter alsoincludes an elongated body having a proximal section, a distal section,and a port at a distal tip of the distal section. An inner lumen extendsfrom the distal tip of the elongated body to the port at the proximalend of the handle. The inner lumen is configured to slidably receive theintrauterine medical apparatus through the port at the proximal end ofthe handle. The elongated body is constructed such that the distalsection includes a distal portion and a proximal portion, wherein thedistal portion is more flexible than the proximal portion, and theproximal portion is more flexible than the proximal section of theelongated body. The elongated body is further constructed such that atleast one of the distal portion and proximal portion is configured tobend to facilitate entry within the patient's cervix.

In another aspect, an intrauterine system includes a medical apparatusconfigured for placement in an intrauterine cavity at a location betweenan infant and uterine walls. The system also includes a catheterconfigured to place, e.g., navigate and deliver, the medical apparatusthrough a patient's cervix. The catheter includes a handle having aproximal end, a distal end, and a port at the proximal end; and anelongated body having a proximal section, a distal section, and a portat a distal tip of the distal section. An inner lumen extends from thedistal tip of the elongated body to the port at the proximal end of thehandle. The inner lumen is configured to slidably receive the medicalapparatus through the port at the proximal end of the handle.

In yet another aspect, a birthing system for augmenting expulsiveuterine forces towards a cervical canal during delivery of a fetus froma uterus, includes a medical apparatus, a catheter, and a controller.The medical apparatus includes a balloon body configured to be placed inan intrauterine cavity at a location between an infant and uterinewalls, and to be operated, e.g., expanded and contracted, there from.The balloon body is configured to transition between a compacted stateand an expanded state. When in the expanded state the balloon bodyapplies a force to a base of the fetus in a direction of the cervicalcanal. The catheter is configured to receive the medical apparatus,circumnavigate the fetus and one or more structures within the uterus toplace the balloon body in the intrauterine cavity at the locationbetween the infant and the uterine walls, and obtain electrical signalsindicative of intrinsic uterine contractions. The controller isconfigured to monitor an intrinsic uterine contraction based on theelectrical signals, and deliver or discharge agent to or from theballoon body to thereby mediate a force generated via the balloon bodyduring the intrinsic uterine contraction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of an access catheter including an elongatedbody and a handle.

FIG. 2 is cross section illustration of the elongated body of the accesscatheter of FIG. 1.

FIG. 3 is an illustration of a configuration of the access catheter ofFIG. 1 including electrode sensors.

FIG. 4 is an illustration of a configuration of the access catheter ofFIG. 1 including a deflectable distal section.

FIG. 5 is an illustration of a navigation controller for deflecting thedistal section of FIG. 4.

FIG. 6 is an illustration of a medical system including the accesscatheter of FIG. 1, a medical balloon apparatus placed within thecatheter, and a controller.

FIG. 7 is an illustration of an access catheter partially introduced inan intrauterine cavity.

FIG. 8 is an illustration of an access catheter further introduced in anintrauterine cavity.

FIG. 9 is an illustration of a balloon body of a medical apparatusexiting an access catheter.

FIG. 10 is an illustration of the medical balloon apparatus of FIG. 9positioned in an intrauterine cavity, in an expanded, deployed state.

FIG. 11 is a flow chart of a method of augmenting expulsive uterineforces towards a cervical canal during delivery of a fetus from auterus.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appendeddrawings is intended as a description of various configurations and isnot intended to represent the only configurations in which the conceptsdescribed herein may be practiced. The detailed description includesspecific details for the purpose of providing a thorough understandingof various concepts. However, it will be apparent to those skilled inthe art that these concepts may be practiced without these specificdetails. In some instances, well known structures and components areshown in block diagram form in order to avoid obscuring such concepts.

Disclosed herein is a minimally invasive access catheter and method forgaining access to a proximal region of a uterus for the purposes ofdelivering, deploying and operating a peripheral intrauterine medicalapparatus to assist infant descent during natural child birth. Thecatheter contains an internal lumen for supporting the medical apparatusduring deployment.

The catheter is configured to circumnavigate an infant, umbilical cord,and uterine structures and to thereby allow for non-surgical access tothe uterus in order to place the medical apparatus in line with theinfant and birth canal during parturition. The catheter may alsofacilitate operation of the medical apparatus by providing physicalsupport for a conduit body of the medical apparatus that delivers apressurized gas or fluid agent to an expandable member of the medicalapparatus. The catheter may also provide a biofeedback platform duringthe natural labor process. For example, the catheter may provide for thesensing of intrinsic uterine contractions through electrical sensors ormechanical sensors, e.g., pressure sensors, integrated with thecatheter. The catheter can be used to place and operate the medicalapparatus for prophylactic use and labor relief during early stage Ilabor, or upon diagnosis of abnormal labor or insufficient infantdescent (dystocia, or the “failure to descend”) due to insufficientuterine contractility during stage II labor.

In use, the catheter is inserted and advanced through the vaginal andcervical canal. The catheter contains a user operated steering mechanismto direct the distal tip of the catheter around intrauterine structuresincluding the fetus, placenta, umbilical cord, to safely advance thecatheter tip to a position near the fundus between the infant andendometrial lining near the proximal end of the uterine cavity. Uponaccessing the target location, the medical apparatus configured toassist infant descent is deployed from the distal tip of the catheter.The catheter may be left in position throughout the duration of labor toprovide physical support for the peripheral medical apparatus, and as asensor platform for monitoring labor progress, maternal and fetal bioparameters. For example, the catheter may include electrodes that senseand conduct signals corresponding to uterine contractions andphysiologic effects. Following delivery of the infant, the catheter maybe used as a support structure for withdrawing the medical apparatusfrom the intrauterine cavity through the birth canal.

The peripheral medical apparatus may be a balloon apparatus such asdescribed in co-pending U.S. patent application Ser. No. ______, titled“Intrauterine Balloon Apparatus, System, and Method for AugmentingUterine Birthing Forces During Parturition” [Attorney Docket No.037262.00003], the entire disclosure of which is herein incorporated byreference. The balloon apparatus is configured to be at least partiallycontained within a lumen of the catheter, and is designed to slide outof the catheter lumen and the distal tip of the catheter duringdeployment and expansion. The balloon apparatus may be packaged in acompacted manner to reduce displacement volume and circumferentialdiameter during the placement procedure, and deployed and expanded intothe uterine cavity by introducing a pressurized agent through a lumen ofthe balloon body into the balloon body. The internal surface of thecatheter lumen may have a high lubricity to facilitate this deploymentaction and reduce friction between the lumen and the exterior of theballoon apparatus.

The catheter may include one or more spaced apart markers for measuringthe depth of insertion by visual inspection, and differing reflectivematerial properties for visualizing the catheter position relative tointernal anatomical structures with the use of external ultrasoundimaging equipment. The catheter may be utilized in conjunction with oneor more additional barriers for preventing the catheter from introducingcontaminants in the birth canal into the uterine cavity or infant(s). Amechanical or chemical barrier, such as a sheath or fluid gel basedsubstance, shields the distal end and catheter body as it passes throughthe vaginal and cervical canals thereby reducing the likelihood ofdirect contact between the catheter and the walls of the birth canal asit reaches the uterine cavity.

FIG. 1 is an illustration of an access catheter 100 including anelongated body 102 and a handle 104. The elongated body 102 includes adistal section 106 and a proximal section 108. The distal section 106may have a length of about 2 centimeters (cm) to about 13 cm, and mayinclude a distal portion 118 and a proximal portion 120. At least one ofthe distal portion 118 and proximal portion 120 may be formed with acurve (not shown) or configured to bend to facilitate entry within thepatient's cervix.

The elongated 102 is configured so that the distal portion 118 is moreflexible than the proximal portion 120, and the proximal portion is moreflexible than the proximal section 108 of the elongated body. To thisend, the distal portion 118 may be formed of a polymer material having ahardness of about 10 D to about 60 D (Shore); the proximal portion 120may be formed of a polymer material having a hardness of about 30 D toabout 80 D (Shore); and the proximal section 108 of the elongated bodymay be formed of a polymer material having a hardness of about 60 D toabout 85 D (Shore).

The elongated body 102 may also include an intermediate section 110between the distal section 106 and the proximal section 108. Theintermediate section 110 may have a flexibility that is greater than theproximal section 108 and less than the distal section 106. Theintermediate section 110 may have a hardness of about 30 D to about 60 D(Shore), and a length of about 1 centimeter to about 8 cm.

The handle 104 includes a proximal end 130, a distal end 132, and aproximal port 126 at the proximal end. A central lumen 116 extends froma port 114 at the distal tip 112 of the elongated body 102, through theentirety of the elongated body and the handle 104, to the proximal port126 at the proximal end 130 of the handle 104. The central lumen 116 isconfigured to slidably receive a medical apparatus through the proximalport 126 at the proximal end 130 of the handle 104. In a configurationwhere the distal section 106 is curved, the distal port 114 in thedistal tip 112 is directed away from a longitudinal axis 134 of theproximal section 108. The distal port 114 at the distal tip 112, and theproximal port 126 at the proximal end 130 of the handle 104 have adiameter equal to the diameter of the central lumen 116.

In some configurations, as described below with reference to FIG. 3, thecatheter 100 may include sensors for providing signals corresponding tobiological or physiologic activity. In such configurations, the handle104 of the catheter 100 may include a connector 136 that provides forelectrical connection between the sensors and a controller configured toprocess the signals.

FIG. 2 is cross section illustration of the elongated body 102 of theaccess catheter 100 of FIG. 1. The elongated body 102 includes a firstor central lumen 116 traversing the entire length of the body. Asdescribed above with reference to FIG. 1, the central lumen 116 isconfigured to receive and contain a peripheral medical apparatus. Theelongated body 102 also includes a second lumen 202 that contains atension wire 204. As described further below, the tension wire 204 maybe used to deflect the distal section 106 of the catheter. The elongatedbody 102 may also include a third lumen 206 that contains one or moreinsulated electrical wires 208. As described further below, theelectrical wires 208 may electrically couple electrodes at the distalsection 106 with a connector at the proximal end 130 of the elongatedbody. The size of each lumen 202, 206 is sufficient for its intendedpurpose.

The elongated body 102 is made of a flexible and resilient biocompatiblematerial, such as a medical grade silicone elastomer, and includes alongitudinally extending tubular wall 210. The tubular wall 210 includesa radially inner surface 212 and a radially outer surface 214, bothwhich extend the entire length of the elongated body 102. The innersurface 212 of the central lumen 116 has a low coefficient of frictionto allow for ease in movement there through of a medical apparatus. Withreference to FIG. 1, the central lumen 116 is open at the distal end ofthe central lumen and thereby defines the distal port 114 of theelongated body 102. The central lumen 116 is also open at the proximalend 130 of the handle and thereby defines the proximal port 126.

FIG. 3 is an illustration of a configuration of an access catheter 100including electrical activity sensors. The electrical activity sensorsmay be a series of ring electrodes 302 mounted on the non-conductivesurface of the elongated body 102 on or near the distal section 106. Thering electrodes 302 may be made of any suitable solid conductivematerial, such as platinum or gold, preferably a combination of platinumand iridium, and may be mounted onto the elongated body 102 with glue orthe like. Alternatively, the ring electrodes 302 can be formed bycoating the non-conductive surface of the elongated body 102 with anelectrically conducting material, such as platinum, gold and/or iridium.The coating can be applied using sputtering, ion beam deposition or anequivalent technique.

The ring electrodes 302 are attached to electrical wires 208 traversingthe length of the elongated body 102 and are coupled to the connector136 associated with the handle 104. The electrical wires 208 are coatedwith electrical insulation layer and conduct electric signals receivedfrom the ring electrodes 302 to the connector 136. Electric insulationlayer may be a coating, a film, or a tube-like component and may becomprised of, for example, Parylene, silicon nitride, silicon oxide, orTeflon.

The ring electrodes 302 may be mounted by first forming a hole in theelongated body 102. An electrical wire 208 is fed through the hole, andthe ring electrode 302 is welded in place over the wire and theelongated body 102. The electrical wires 208 extend through the wall ofthe elongated body 102 and into a lumen 206 of the elongated body, suchas the third lumen 206 shown in FIG. 2. The proximal end of eachelectrical wire 208 is electrically connected to the connector 136,which in turn, is connected to an appropriate controller or other devicefor receiving signals from the electrode. The controller is configuredto process the electrical activity signals and to extrapolate uterinecontraction states for providing guidance on the timing of operation ofthe medical apparatus deployed by the catheter. The location and spacingof the ring electrodes 302 are sufficient to sense local and globaluterine contractions. In one arrangement, at least one electrode 302 isplaced near the distal tip 112 of the elongated body 102 and anotherelectrode is placed a sufficient distance to allow for discrimination ofsignals from noise and for monitoring of electrical activity indicativeof uterine contraction onset and propagation.

FIG. 4 is an illustration of a configuration of the access catheter 100including a deflectable distal section 106. In this configuration, thedistal section 106 is made of a suitable biomaterial of about 10 D toabout 60 D (Shore) for softer deflectable capabilities and has a length402 of about 5 cm to about 13 cm. Deflection 404 of the distal section106 to a curvature 406 is accomplished by suitable tension from atension wire 204 through movement of the manipulation mechanism 122 ofthe handle 104 resulting in longitudinal movement of the tension wire204 relative to the elongated body 102. The distal section 106 may befabricated of a flexible resilient material so that it tends to assume aparticular shape when at rest.

The tension wire 204 is affixed at one or more attachment points 408along the inner curvature of the distal section 106, resulting in aninward deflection of the distal tip 112 upon application of tensionthrough the tension wire 204. Upon release of the tension from thetension wire 204, the distal section 106 assumes its original shape. Theoriginal shape by be straight or it may be curved. When a deflectionforce is imparted to the distal section 106 to achieve deflection 404,the inherent construction of the distal section exerts an opposing, orstraightening restoring force, that tends to return the body member toits “at rest” shape. In the case of FIG. 1, the distal section 106assumes a relatively straight shape when at rest. When enough tension isapplied to the tension wire 204, deflection occurs but the body memberapplies an opposing straightening force. When all deflection forces havebeen removed from the distal section 106, this force created by theconstruction of the distal section returns the distal section to astraightened position.

As previously described, the tension wire 204 may be attached to thedistal section 106 at one or more attachment points 408 along the lengthof the distal section. These attachment points 408 may be around thecircumference of the distal section 106 to provide for a more uniformapplication of force across the catheter cross sectional area.Attachment points 408 located as such provide suitable strain relief andreduce the likelihood of damage to the elongated body 102 or lumens dueto tension applied from the tension wire 204.

FIG. 5 is an illustration of a navigation controller for deflecting thedistal section of FIG. 4. The handle 104 includes a user controlledmanipulation mechanism 122 attached to a tension wire 204. Operation ofthe manipulation mechanism 122 applies tension to the tension wire 204for varying the deflection of the distal section. In one configuration,the manipulation mechanism 122 is a knob or circular control wheel onthe handle 104, which enables the user to vary the amount of tensionexerted on the tension wire 204 with the same hand used to hold thecatheter without the need to reposition the hand. A locking mechanism128 is provided in the handle for physically maintaining wire tensionthereby fixing or “locking” the distal section in a deflection state.

Upon diagnosis of abnormal labor including slow infant descent due toinsufficient uterine contractile forces, a birthing professional maydecide that augmentation of intrinsic contraction forces may bebeneficial. To this end the birthing professional may desire to employ amedical system configured for placement in the uterus for purposes ofassisting infant descent during active labor of parturition. The medicalsystem may include the catheter 100 described in FIGS. 1 through 5, anda medical apparatus. The medical apparatus may be as described inco-pending U.S. patent application Ser. No. ______, titled “IntrauterineBalloon Apparatus, System, and Method for Augmenting Uterine BirthingForces During Parturition” [Attorney Docket No. 037262.00003].

FIG. 6 is an illustration of a medical system 600 including an accesscatheter 100, a medical balloon apparatus 602 placed within thecatheter, and a controller 604. The medical balloon apparatus 602include a conduit body 606 and a balloon body 608. The conduit body 606includes a proximal region, a distal region, and an internal lumen 610.The balloon body 608 is coupled to the distal region of the conduit body606 and has an internal chamber in fluid communication with the internallumen of the conduit body. The balloon body 608 is configured totransition between a compacted state (shown in FIG. 6) and an expandedstate (shown in FIG. 10).

The medical balloon apparatus 602 also includes a connector 612. Theconnector 612 is configured to connect the medical balloon apparatus 602to the controller 604 and provide an interface between the internallumen 610 of the conduit body 606 and an agent source, such as afluid/gas source 614, associated with the controller. The fluid/gassource 614 may be associated with the controller 604 through a pump 616,which may operate under control of the controller 604. The conduit body606 enables bidirectional agent conduction between the agent source 614and balloon body 608 through the internal lumen 610.

The catheter 100 is used to place the medical balloon apparatus 602 inthe intrauterine cavity. To this end, and with reference to FIGS. 1 and6, the medical balloon apparatus 602 may be inserted into the centrallumen 116 of the catheter 100 through the proximal port 126 of thecatheter. The medical balloon apparatus 602 may be advanced through thecentral lumen 116 until the balloon body 608 is within either of thedistal section 106 of the catheter or the intermediate section 110 ofthe catheter. Placement of the balloon body 608 in the distal section106 may impede deflection of the distal section. Accordingly, it may bebeneficial to place the balloon body 608 within the intermediate section110. Once appropriately positioned within the catheter 100, the medicalballoon apparatus 602 may be locked in place by the locking mechanism128. The catheter 100 may then be used to place and deploy the medicalballoon apparatus 602 in an intrauterine cavity.

FIG. 7 is an illustration of an access catheter 100 partially introducedin an intrauterine cavity. A user places the distal tip 112 of theelongated body 102 through the entrance of the birth canal cervicalwalls 702 of the patient and between the fetus 704 and the distal areaof the uterine walls 706. The diameter of the elongated body 102 issized for minimal displacement of internal uterine structures during theplacement procedure and includes a sufficiently sized distal tip 112 fornavigating a minimally intrusive pathway to the proximal area of theuterine cavity without the need to transect any internal membranes ororgans. The length 708 of the elongated body 102 is sufficient to reachthe proximal regions of the intrauterine cavity near the fundus 710while providing sufficient externalized extracorporeal length 712 formanipulation and connection of the catheter by the user to a controllerduring the birthing procedure.

FIG. 8 is an illustration of illustration of an access catheter 100further introduced in an intrauterine cavity. The user advances thecatheter 100 along the uterine cavity walls to the target location nearthe fundus 710 of the uterus, safely circumnavigating structures withinthe uterine cavity including the fetus 704, umbilical cord 802, andplacenta 804 to the proximal region 806 of the uterus. The user maynavigate the catheter 100 using a combination of actions includingrotating the handle 104 to rotate the entire catheter 100, manipulatingthe manipulation mechanism 122 to deflect the distal tip 112, and/oradvancing and partially retracting the catheter 100 to direct theassembly towards the desired location. The user may be aided by visualand echogenic markers 124 located along the elongated body 102 fordetermining the inserted distance and the relative position of thedistal tip 112. The elongated body 102 is sufficiently stiff to enabletorque and reduce unwanted body flexion yet sufficiently pliable inorder to conform without applying excessive focal contact pressures withinternal organs, structures, or the infant during either access ornavigation.

In one configuration, the distal tip 112 of the catheter 100 is made ofa material with reduced hardness to reduce the likelihood of incurringdamage to internal uterine structures, infant, or patient duringdelivery with a soft and rounded tip. As described with reference toFIG. 1, the elongated body may include different sections of differentstiffness. An intermediate section 110 may have greater stiffness andless flexion properties than a distal section 106, and a proximalsection 108 may have a greater stiffness than the intermediate section110 for enabling efficient torque and advancement force transfer to thecatheter body.

With reference to FIGS. 6 and 8, upon positioning of the distal tip 112at the desired intrauterine location, the balloon body 608 may beadvanced through the distal tip to allow for expansion of the balloonbody. The balloon body 608 may be made to exit through the distal tip112 by either pushing the conduit of the medical apparatus in a distaldirection or by pulling the catheter 100 in a proximal direction or acombination of both. The balloon body 608 may also be made to exitthrough the distal tip 112 using pressurized agent. To this end, theconnector 612 of the medical balloon apparatus 602 extending from theproximal port of the handle 104 may be connected with a coupler 618 ofthe controller 604 to create a hermetically sealed fluid communicationpath between the internal lumen 610 of the conduit body 606 and thecontroller for supplying pressurized agent from the agent source 614 tothe balloon body 608 of the medical balloon apparatus 602. Onceconnected, agent may be delivered through the conduit body 606 to theballoon body 608. The pressure at the balloon body 608 imparts a forcein the distal direction of the catheter 100 and causes the balloon bodyand conduit body 606 to slide in the distal direction. The force may besufficient enough to cause the entire balloon body 608 to exit thedistal tip 112 of the catheter 100.

FIG. 9 is an illustration of a balloon body 608 of a medical apparatusexiting an access catheter 100 through the distal port 114 of thecatheter. As just described, pressurized fluid air or gas injection 902results in deployment of forces. Upon sufficient gas or fluid agentdischarge, the medical balloon apparatus 602 may move relative to theelongated body 102 of the catheter 100 causing the medical balloonapparatus to displace towards the distal tip 112 of the catheter so thatthe compressed balloon body 608 may extend beyond the distal tip. Oncethe balloon body 608 exits the catheter 100, the rate of delivery ofagent may be increased to thereby expand the balloon body to impartforces.

FIG. 10 is an illustration of the medical balloon apparatus 602positioned in an intrauterine cavity, while in an expanded, deployedstate. FIG. 10 shows the balloon body 608 during expansion relative tothe fetus 704, umbilical cord 802, placenta 804, uterine walls 706, andcervical canal 702. For clarity of illustration, the catheter 100 (shownin FIG. 8) used to place the medical balloon apparatus is not shown inFIG. 10.

Throughout inflation of the balloon body 608, a proximal wall 1004 ofthe balloon body faces the fetus 704 and cervical canal 702. Due to thedesigns of the balloon body 608, the balloon body predominantly expandsin the direction generally along an axis 1006 passing through the uterusand the cervical canal 702. Accordingly, directional forces 1008resulting from expansion of the balloon body 608 are applied to the base1002 of the fetus. As the fetus 704 descends, the balloon body 608 isfurther expanded in order to maintain the application of the directionalforces 1008. As such, directional forces 1008 are applied throughoutinfant descent through the cervical canal 702. Predominant expansion ofthe balloon body 608 in the direction along the axis 1006 in thedirection of the cervical canal 702 reduces expansion of the balloonbody in other directions. This is beneficial in that it reduces theamount of forces applied to other intrauterine structures, e.g., theuterine walls 706, and parts of the fetus 704 other than the base 1002.

FIG. 11 is a flow chart of a method of augmenting expulsive intrinsicuterine forces towards a cervical canal during delivery of a fetus froma uterus. The method may be performed by the medical system 600 of FIG.6.

At step 1102, the system 600 monitors an intrinsic uterine contraction.The intrinsic uterine contraction may be an onset of a contraction or itmay be a change in state of an occurring contraction that results ineither an increase in intrinsic intrauterine pressure or forces or adecrease in intrinsic intrauterine pressure or forces. The onset andpressure state of a uterine contraction may be monitored for by thecontroller 604 based on electrical activity sensed from the uterus andthe processing of the sensed electrical activity. For example,morphology analysis of the sensed electrical activity may detect anonset of a contraction and changes in the pressure state of thecontraction. The onset and pressure state of a uterine contraction alsomay be monitored for by the controller 604 based on sensed pressures. Inone configuration, pressures are sensed through the conduit body 606,wherein such pressures are indicative of pressure within the uterus. Inanother configuration, an intrauterine pressure measurement may beobtained from a pressure sensor associated with a medical balloonapparatus 602 that is delivered in the uterus.

At step 1104, if an onset of an intrinsic uterine contraction or achange in state of an ongoing contraction is not detected by the system600, the process returns to step 1102. If onset of an intrinsic uterinecontraction or a change in state of an ongoing contraction is detected,the process proceeds to step 1106, where the system 600 mediates a forcegenerated via a medical balloon apparatus 602 located in the uterus. Theforce is directed toward the cervical canal and augments naturalexpulsive uterine forces. In one configuration, the medical balloonapparatus 602 includes a balloon body 608 positioned at a proximaluterine location adjacent the fetus. For example, as shown in FIG. 10,the balloon body 608 may be positioned between the base 1002 of thefetus 704 and the fundus 710. The force is generated by delivering anagent to the balloon body 608 to thereby expand the balloon body towardthe cervical canal 702 and into contact with the base 1002 of the fetus704.

Upon either a detection of an onset of an intrinsic uterine contraction,or an increase in uterine contraction forces, the system 600 may mediatethe force by delivering an agent to the balloon body 608 to at leastpartially expand the balloon body toward the cervical canal 702 and intocontact with the base 1002 of the fetus 704. Upon a detection of adecrease in uterine contraction forces, the system 600 may mediate theforce by discharging an agent from the balloon body 608 to at leastpartially collapse the balloon body away from the fetus 704 and thecervical canal 702. As a safety measure, the system 600 may also mediatethe force by discharging an agent from the balloon body 608 when ameasured pressure associated with the medical balloon apparatus exceedsa threshold value, such as 200 mmHg.

The forces applied by the medical balloon apparatus 602 are mediated byincreasing and decreasing the agent delivered through the conduit bodyfor constructively augmenting uterine pressures generated by intrinsiccontractions. A target pressure or pressure based objective is setwithin the controller 604 and used to define the target balloon pressureresulting from agent delivery. To this end, the controller 604 mayinclude a memory for storing program code and a processor that operatesin accordance with the code to implement the process of FIG. 11.Accordingly, the controller 604 may be considered a special purposecomputer that is configured to—in conjunction with a medical balloonapparatus 602 having a balloon body 608 configured to be positioned inthe uterus—monitor an intrinsic uterine contraction, and mediate a forcegenerated via the balloon body during the intrinsic uterine contraction,wherein the force is directed toward the cervical canal and augmentsnatural expulsive uterine forces.

The controller 604 is further configured to implement subprocessesassociated with monitoring and mediating. For example, the controller604 may be configured to monitor an intrinsic uterine contraction byobtaining one or more of pressure signals and electrical signalsindicative of an intrinsic uterine contraction. As described above,these signals may be provided by sensors associated with the medicalballoon apparatus. The controller 604 includes program code that allowsthe processor of the controller to detect at least one of an onset of anintrinsic uterine contraction, an increase in uterine contractionforces, and a decrease in uterine contraction forces based on the one ormore of pressure signals and electrical signals. To this end, thecontroller may process the signals to obtain corresponding measurementsand compare the measurements to threshold values stored in memory thatrepresent a contraction onset, or a change (e.g., increase or decrease)in uterine contraction force that warrants mediation.

With respect to mediation, the controller 604 may be configured todeliver an agent to the balloon body 608 to at least partially expandthe balloon body toward the cervical canal and into contact with thefetus upon either of a detection of an onset of an intrinsic uterinecontraction, or an increase in uterine contraction forces. Thecontroller 604 may be configured to discharge an agent from the balloonbody 608 to at least partially collapse the balloon body away from thefetus and the cervical canal upon a detection of a decrease in uterinecontraction forces. As describe previously, an increase or decrease inuterine contraction forces may be warranted when the controller 604detects a corresponding increase or decrease in pressure due tointrinsic uterine activity that satisfies a threshold criterion. Thecontroller 604 may also be configured to discharge an agent from theballoon body 608 when a measured pressure associated with the medicalballoon apparatus exceeds a maximum allowed threshold value.

The previous description is provided to enable any person skilled in theart to practice the various aspects described herein. Variousmodifications to these aspects will be readily apparent to those skilledin the art, and the generic principles defined herein may be applied toother aspects. For instance the handle for catheter navigation may be ofvarious form factors or operational orientation, the connector to anexternal controller may bifurcate separating mechanical from electricalconduits and connectors, the cross sectional locations, number and sizesof internal lumens may vary to perform the stated functions, and thecatheter may be physically connected to part of the deployed peripheralmedical apparatus. Furthermore, nearly an infinite number of variationsof electrode size and lengths, and/or catheter lengths and diameters maybe utilized. These and other modifications obvious to those skilled inthe medical apparatus arts are intended to be within the scope.

Disclosed herein is a catheter 100 configured to be delivered throughthe cervical canal, accessing the uterine cavity between the infant andmother's endometrium lining, for purposes of assisting birthing. Inanother configuration, the catheter 100 may be configured to bedelivered through the maternal abdomen, accessing the abdominal cavitynear the perimetrium of the uterus, for purposes of assisting birthing.In either configuration, the catheter 100 may be used as a conduitand/or diffuser for forces or pressure including hydraulic pressure,fluids including air, saline, lubricants, antibiotics or othersubstances, placing a medical device to target locations near theuterine walls, or combinations thereof.

The catheter 100 may include a sheath, guidewire, flexible tubing orother guidance system to assist navigation through the cervical canaland reaching a targeted intrauterine location. The catheter 100 mayinclude a physical covering, sheath, outer lumen, or other antibioticagent, for passage through vaginal or abdominal cavities, to reduceexposure of the catheter body itself to areas with higher risk ofpotential pathogens. The catheter 100 may utilize an inflatablediaphragm at the distal end of the catheter. The catheter 100 mayincorporate one or more lumens for conducting fluids and/or providingdesired handling properties of the catheter. The catheter 100 mayinclude one or more sensors for detecting and monitoring uterinecontraction timing, forces and effects from the abdominal muscles,myometrial uterine muscles, or other applied forces during labor. Thecatheter 100 may include one or more sensors for detecting andmonitoring applied forces and their direction including those exerted byone or more medical devices, e.g., a medical balloon apparatus.

The catheter 100 may be made from a flexible, pliable, biocompatiblematerial including but not limited to silicone, polyurethane, polyvinylchloride, polyethylene or polytetraflouroethylene (Teflon), andcombinations or blends thereof. The catheter 100 may be attached at theproximal end to a reservoir, tubing, or relief valve for deliveringfluids or conducting forces into the distal tip, at one or more pointsalong the birth canal, or into a separate medical device. The fluidsdelivered include lubricants, antibiotics, air, synthetic hormones,biosimilars, or saline. The catheter 100 may be attached to an externalmedical device, e.g., a controller, utilizing the information measuredfrom a sensor integrated into the catheter for detecting applied forcesand their direction in the uterus, infant(s), or combination thereof.The catheter 100 may be configured to enable visualization withinintrauterine cavity of physical relationships between the uterine wall,birth canal, one or more fetus(es), placenta, or umbilical cord(s),during delivery. The catheter 100 may be configured to conduct ortransmit data from sensors to a controller having hardware designed tofilter, process, analyze and display or incorporate into an algorithm.The catheter 100 may be attached to an inflatable balloon or otherplessary device at the proximal end of the catheter for the purpose ofcervical ripening. The catheter 100 may be used during the prepartum orintrapartum stage of the birthing process.

Thus, the claims are not intended to be limited to the aspects shownherein, but is to be accorded the full scope consistent with thelanguage claims, wherein reference to an element in the singular is notintended to mean “one and only one” unless specifically so stated, butrather “one or more.” The word “exemplary” is used herein to mean“serving as an example, instance, or illustration.” Any aspect describedherein as “exemplary” is not necessarily to be construed as preferred oradvantageous over other aspects. All structural and functionalequivalents to the elements of the various aspects described throughoutthis disclosure that are known or later come to be known to those ofordinary skill in the art are expressly incorporated herein by referenceand are intended to be encompassed by the claims. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the claims. No claimelement is to be construed as a means plus function unless the elementis expressly recited using the phrase “means for.”

What is claimed is:
 1. A catheter for directing an intrauterine medicalapparatus via a patient's cervix, the catheter comprising: a handlehaving a proximal end, a distal end, and a port at the proximal end; anelongated body having a proximal section, a distal section, and a portat a distal tip of the distal section; and an inner lumen extending fromthe distal tip of the elongated body to the port at the proximal end ofthe handle, the inner lumen configured to slidably receive theintrauterine medical apparatus through the port at the proximal end ofthe handle, wherein the distal section comprises a distal portion and aproximal portion, the distal portion being more flexible than theproximal portion, and the proximal portion being more flexible than theproximal section of the elongated body, and at least one of the distalportion and proximal portion being configured to bend to facilitateentry within the patient's cervix.
 2. The catheter of claim 1, whereinthe distal section of the elongated body has a length of about 2centimeters to about 13 centimeters.
 3. The catheter of claim 1, whereinthe distal portion of the distal section is formed of a polymer materialhaving a hardness of about 10 D to about 60 D (Shore).
 4. The catheterof claim 1, wherein the proximal portion of the distal section is formedof a polymer material having a hardness of about 30 D to about 80 D(Shore).
 5. The catheter of claim 1, wherein the proximal section of theelongated body is formed of a polymer material having a hardness ofabout 60 D to about 85 D (Shore).
 6. The catheter of claim 1, whereinthe elongated body further comprises an intermediate section between theproximal section and the distal section, the intermediate section beingmore flexible than the proximal section and less flexible than thedistal section.
 7. The catheter of claim 6, wherein the intermediatesection of the elongated body has a hardness of about 30 D to about 60 D(Shore).
 8. The catheter of claim 6, wherein the intermediate section ofthe elongated body has a length of about 1 centimeter to about 8centimeters.
 9. The catheter of claim 1, wherein the distal section isformed with a curve so that the port in the distal tip is directed awayfrom a longitudinal axis of the proximal section.
 10. The catheter ofclaim 1, wherein the port in the distal tip has a diameter equal to thediameter of the inner lumen.
 11. The catheter of claim 1, furthercomprises a plurality of sensing electrodes at the distal section, anelectrical connector associated with the handle, and a plurality ofelectrical wires electrically connecting the plurality of sensingelectrodes to the electrical connector.
 12. An intrauterine systemcomprising: a medical apparatus configured for placement in anintrauterine cavity at a location between an infant and uterine walls;and a catheter configured to place the medical apparatus via a patient'scervix, the catheter comprising: a handle having a proximal end, adistal end, and a port at the proximal end; an elongated body having aproximal section, a distal section, a port at a distal tip of the distalsection, and an inner lumen extending from the distal tip of theelongated body to the port at the proximal end of the handle, the innerlumen configured to slidably receive the medical apparatus through theport at the proximal end of the handle.
 13. The intrauterine system ofclaim 12, wherein the distal section comprises a distal portion and aproximal portion, the distal portion being more flexible than theproximal portion, and the proximal portion being more flexible than theproximal section of the elongated body, and at least one of the distalportion and proximal portion being configured to bend to facilitateentry within the patient's cervix.
 14. The intrauterine system of claim12, wherein the catheter further comprises a plurality of sensingelectrodes at the distal section, an electrical connector associatedwith the handle, and a plurality of electrical wires electricallyconnecting the plurality of sensing electrodes to the electricalconnector.
 15. The intrauterine system of claim 12, wherein the medicalapparatus comprises: a conduit body having a proximal region, a distalregion, and an internal lumen; and a balloon body coupled to the distalregion of the conduit body and having an internal chamber in fluidcommunication with the internal lumen of the conduit body, the balloonbody configured to be placed in an intrauterine cavity at a locationbetween an infant and uterine walls and to transition between acompacted state and an expanded state, wherein when in the expandedstate the balloon body applies a force to a base of the infant in adirection of a cervical canal.
 16. A birthing system for augmentingexpulsive uterine forces towards a cervical canal during delivery of afetus from a uterus, the birthing system comprising: a medical apparatushaving a balloon body configured to be placed in an intrauterine cavityat a location between an infant and uterine walls, the balloon bodyconfigured to transition between a compacted state and an expandedstate, wherein when in the expanded state the balloon body applies aforce to a base of the fetus in a direction of the cervical canal; acatheter configured to receive the medical apparatus, circumnavigate thefetus and one or more structures within the uterus to place the balloonbody in the intrauterine cavity at the location between the infant andthe uterine walls, and obtain electrical signals indicative of intrinsicuterine contractions; and a controller configured to monitor anintrinsic uterine contraction based on the electrical signals, anddeliver or discharge agent to or from the balloon body to therebymediate a force generated via the balloon body during the intrinsicuterine contraction.
 17. The birthing system of claim 16, wherein themedical apparatus further comprises a conduit body having a proximalregion, a distal region, and an internal lumen, wherein the balloon bodyis coupled to the distal region of the conduit body and has an internalchamber in fluid communication with the internal lumen of the conduitbody.
 18. The birthing system of claim 16, wherein the cathetercomprises: a handle having a proximal end, a distal end, and a port atthe proximal end; an elongated body having a proximal section, a distalsection, a port at a distal tip of the distal section; and an innerlumen extending from the distal tip of the elongated body to the port atthe proximal end of the handle, the inner lumen configured to slidablyreceive the medical apparatus through the port at the proximal end ofthe handle.
 19. The birthing system of claim 18, wherein the catheterfurther comprises: a plurality of sensors at the distal sectionconfigured to sense signals indicative of intrinsic uterinecontractions; a connector associated with the handle; and a plurality ofelectrical wires electrically connecting the plurality of sensors to thecontroller through the connector associated with the handle.